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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03052673 |
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Date of registration:
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06/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ketamine for Pain Relief in Bariatric Surgery
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Scientific title:
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Per-operative Low-Dose Ketamine For Postoperative Pain Relief In Patients Undergoing Bariatric Surgery: A Randomised Study |
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Date of first enrolment:
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February 20, 2017 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03052673 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Amitabh Dutta, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir Ganga Ram Hospital, New Delhi, INDIA |
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Name:
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Anil K Jain, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir Ganga Ram Hospital, New Delhi, INDIA |
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Name:
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Haider Hussain, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir Ganga Ram Hospital, New Delhi, INDIA |
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Name:
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Nitin Sethi, DNB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir Ganga Ram Hospital, New Delhi, INDIA |
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Name:
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Praveen Bhatia, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir Ganga Ram Hospital, New Delhi, INDIA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients of age 18-60 years
- BMI > 35 kg/m2
- Either sex
- ASA physical status II & III
- undergoing laparoscopic bariatric surgery
Exclusion Criteria:
- Patients refusal
- ASA physical status: IV
- History of hypersensitivity to fentanyl and/or ketamine
- Chronic opioid use
- History of substance abuse
- Metabolic disorders
- Seizure disorder
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Drug: ketamine
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Drug: Fentanyl
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Primary Outcome(s)
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Efficacy of Postoperative Analgesia
[Time Frame: From end of anaesthesia till 24-hours postoperatively]
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Postoperative Fentanyl Consumption in micrograms
[Time Frame: From end of anaesthesia till 24-hours postoperatively]
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Secondary Outcome(s)
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Postoperative Nausea and Vomiting
[Time Frame: From end of anaesthesia till 24-hours postoperatively]
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Time to extubation in minutes
[Time Frame: From end of anaesthesia till 30-minutes postoperatively]
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Changes in intraoperative blood pressure- systolic, diastolic, and mean (mmHg)
[Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively]
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Time to eye opening in minutes
[Time Frame: From end of anaesthesia till 20-minutes postoperatively]
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Changes in intraoperative heart rate (beats per minute)
[Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively]
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Postoperative Sedation
[Time Frame: From end of anaesthesia till 24-hours postoperatively]
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Secondary ID(s)
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EC/01/17/1120
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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